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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078166

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NDA 078166 describes CIPROFLOXACIN EXTENDED RELEASE, which is a drug marketed by Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Fosun Pharma, and Mylan Pharms Inc, and is included in six NDAs. It is available from three suppliers. Additional details are available on the CIPROFLOXACIN EXTENDED RELEASE profile page.

The generic ingredient in CIPROFLOXACIN EXTENDED RELEASE is ciprofloxacin; ciprofloxacin hydrochloride. There are thirty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin; ciprofloxacin hydrochloride profile page.
Summary for 078166
Applicant:Anchen Pharms
Ingredient:ciprofloxacin; ciprofloxacin hydrochloride
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength425.2MG;EQ 574.9MG BASE
Approval Date:Nov 27, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength212.6MG;EQ 287.5MG BASE
Approval Date:Nov 27, 2007TE:ABRLD:No

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